Simultaneous determination of tinidazole and lidocaine by high performance liquid chromatography

Tinidazole is effective in most of the anaerobic bacteria and Gardnerella vaginalis with Trichomonas vaginalis, Giardia lamblia and Entamoeba histolytica with its mechanism of action against protozoa and anaeorabic bacteria. Lidocaine stabilizes the neuron membrane during therapy and blocks nerve conduction and reduces the sensation of burning and itching by acting as a local anesthetic. The pharmaceutical preparation consisting the active agents Tinidazole and Lidocaine; It is effective on the treatment of bacterial vaginasis and trichomoniasis (trichomonas vaginitis) in the vagina. A selective, simple and new reversed phase high performance liquid chromatographic method was developed and validated for determination of tinidazole and lidocaine simultaneously in the ovule dosage form for this study. Developed method was performed with gradient elution by getting C18 (250x4.6mm,5µm) reversed phase HPLC column, mobile phase containing 10mM potassium phosphate buffer(pH3.0), acetonitrile at 1.0 mL/min. Temperature for column and autosampler were adjusted at 25Cº. The chromatographic seperation was done at 220 nm wavelenght. Retention times were found as 6.5 min for lidocaine and 8.2 min. for tinidazole. The purity of each preparation was evaluated getting a photodiode array detector. The linearity ranges were 75-195 µg/mL for tinidazole and 25-65 µg/mL for Lidocaine. The limit of dedection(LOD) and the limit of quantitation (LOQ) results were 0.05625 µg/mL and 0.225 µg/mL for Tinidazole, 0.01875 µg/mL ve 0.075 µg/mL for Lidocaine. The simple, sensitive and reproducible method was developed and performed for tinidazole and lidocaine simultaneous analysis successfully. Keywords: Tinidazole, Lidocaine, High Performance Liquid Chromatography, Validation, Ovule analysis.